Pharmacovigilance senior specialist m/f/d

il y a 1 mois


Bruxelles, Région de Bruxelles, Belgique MSD Temps plein

Senior Pharmacovigilance Specialist

The role of Senior PV Specialist is a crucial part of the Office of the Qualified Person for Pharmacovigilance (QPPV) reporting to the Deputy QPPV or QPPV Office Physician. It involves providing support and oversight for various activities related to the QPPV role.

Key Responsibilities:

  • Supporting the management of the Pharmacovigilance System Master File (PSMF) including interactions with internal stakeholders and external PV inspectors.
  • Liaising with EMA and other regulatory agencies on compliance matters.
  • Assisting the QPPV with specialist projects in pharmacovigilance.

Requirements:

  • Bachelor's degree in biological science, nursing, or pharmacy.
  • Proven experience and training in pharmacovigilance.
  • Familiarity with EU pharmacovigilance requirements.
  • Minimum three years experience in a relevant field with at least eighteen months in a drug safety position.
  • Strong communication, problem-solving, and presentation skills.
  • Ability to build and manage relationships with stakeholders.
  • IT literacy.

Please Note: This is not an entry-level position. Only candidates meeting the specified requirements will be considered.



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